Product Alert

FDA Clears New Indication for NSCLC Drug

WASHINGTON -- Against the wishes of its advisory panel, the FDA has expanded its approval of erlotinib (Tarceva), a second-line drug used in treating non-small cell lung cancer (NSCLC), to include use as a maintenance drug for locally advanced or metastatic NSCLC.

The new indication contradicts the results of 12-to-1 vote in December by the agency's advisory panel, which advised against approving the drug's new use. (See FDA Rejects Earlier Use of Erlotinib)

Although the agency does not have to follow the advice of its expert panels, it usually does so, particularly when the votes are so lopsided.

Erlotinib is already approved to treat NSCLC as a second-line therapy if chemotherapy fails to stop the cancer from spreading. But the agency's Oncologic Drugs Advisory Committee opposed the extension to maintenance treatment, citing modest benefits and the presence of alternative treatments.

Approval of the new indication was based on the results of the phase III SATURN trial, a placebo-controlled, randomized, double-blind study with 889 advanced NSCLC patients.

Patients were treated with four cycles of platinum-based chemotherapy and were randomized to erlotinib or placebo on a one-to-one basis if the cancer did not progress following treatment.

Progression-free survival was measured to determine efficacy and was defined as length of time to disease progression or death after chemotherapy treatment.

Overall survival in patients treated with erlotinib improved 23% compared with those in the placebo group (HR=0.81, P=0.0088). Patients in the erlotinib group also had a 41% improved progression-free survival rate compared with placebo (HR=0.7129, P<0.0001).

Adverse effects in the trial included up to grade 3 rash and diarrhea.

In addition to its two NSCLC-related indications, the treatment is also indicated for use as a first-line treatment against locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine.

Cole Petrochko started his journalism career at MedPage Today in 2009, after graduating from New York University with B.A.s in Journalism and Psychology. When not writing for MedPage Today, he blogs about nerd culture, designs websites, and buys and sells collectible card game cards. He is based out of MedPage Today's Little Falls, N.J. Headquarters.

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